Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr PM Patel

ORCID ID

Contact details

Medical Oncology
Cancer Studies
ICRF Research Building
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436044028

Study information

Scientific title

A phase III randomised, double-blind trial of immunotherapy with a polyvalent melanoma vaccine (C-VAX) plus bacille Calmette-Guerin (BCG) versus placebo plus BCG as a post surgical treatment for stage IV melanoma

Acronym

Study hypothesis

To establish whether adjuvant C-VAX plus BCG will prolong disease free and overall survival compared to placebo plus BCG in stage IV melanoma patients who have no evidence of disease post-surgery.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stage IV melanoma

Intervention

Randomised controlled trial.

Intervention type

Biological/Vaccine

Phase

Not Specified

Drug names

Primary outcome measures

Progression free survival.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1999

Overall trial end date

01/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with resected stage IV melanoma.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/1999

Recruitment end date

01/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes